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MHRA: Guidance on changes to labelling and patient information leaflets for self certification: Inclusion of Braille on the labelling

10.04.2009
From 1 April 2009 compliance with article 56(a) of Council Directive 2001/83/EC may be achieved (in certain prescribed conditions) by means of a Better Regulation of Medicines Initiative (BROMI) notification to update the labelling on a marketing authorisation. Detailed guidance on how to prepare and submit a notification is announced.

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